Indirect Calorimetry Measurement in the Pediatric Intensive Care Unit's Smallest Patients

Официальное название

Indirect Calorimetry Measurement in the Paediatric Intensive Care Unit's Smallest Patients

Обзор

Indirect calorimetry is considered the reference method for measuring energy expenditure in intensive care patients. However, in infants and small children weighing less than 10 kilograms, its clinical use has historically been limited due to technical challenges related to low tidal volumes, potential increases in dead space, and measurement precision. The goal of this observational study is to evaluate the feasibility and performance of indirect calorimetry using the Q-NRG+ device in critically ill children weighing less than 10 kg who are admitted to a pediatric intensive care unit.

Подробное описание

Indirect calorimetry measures oxygen consumption and carbon dioxide production to calculate resting energy expenditure and is considered the reference method in intensive care. In mechanically ventilated pediatric patients, resting energy expenditure is commonly used as a surrogate for total energy expenditure, as activity-related expenditure is minimal due to sedation and ventilation. Despite its clinical relevance, the use of indirect calorimetry in children weighing less than 10 kg has been limited by technical challenges related to low tidal volumes and measurement precision. The Q-NRG+ is an indirect calorimeter designed to measure resting energy expenditure in mechanically ventilated and spontaneously breathing patients.

This prospective, single-center observational study will be conducted in a pediatric intensive care unit. Critically ill children weighing less than 10 kg who require mechanical ventilation or are spontaneously breathing and able to tolerate indirect calorimetry measurement using a canopy hood will be eligible for inclusion. Indirect calorimetry measurements will be performed according to a predefined protocol during the course of critical illness. For the measurement, a sampling module will be connected to the ventilator circuit without increasing ventilator dead space. The system continuously samples inspired and expired gases, and energy expenditure is calculated based on measured oxygen consumption and carbon dioxide production in combination with ventilator parameters.

The primary objective is to evaluate the feasibility of indirect calorimetry using the Q-NRG+ in critically ill children weighing less than 10 kg, defined as the proportion of technically valid and clinically interpretable measurements. Secondary objectives are to describe measured resting energy expenditure (kcal/kg/day) in this population, to evaluate changes in measured energy expenditure over the course of critical illness, and to compare measured energy expenditure with predicted energy requirements calculated using standard predictive equations. Demographic and clinical variables relevant to metabolic status (age, weight, diagnosis, ventilator settings, sedation, and phase of illness) will be collected from medical records. Descriptive and comparative statistical analyses will be performed.

Вмешательства

• Устройство Q-NRG+
  The Q-NRG+ is an indirect calorimetry device used to measure resting energy expenditure in mechanically ventilated or spontaneously breathing patients. In this study, the device is connected to the ventilator circuit or used with a canopy hood to measure oxygen consumption and carbon dioxide production for calculation of energy expenditure. Measurements are performed in addition to standard clinical care and do not alter routine treatment.

Первичные конечные точки

• Feasibility of Q-NRG+ indirect calorimetry measurements [Срок оценки: From first enrollment until end of study (During PICU stay (Q2 2026 - Q4 2027)]

Вторичные конечные точки (5)

• Agreement between carbon dioxide production measured by Q-NRG+ and volumetric capnography, Capnostat 5 [Срок оценки: During PICU stay (Day 1 to Day 7), when simultaneous Q-NRG+ and Capnostat 5 measurements are available (up to 5 measurements per patient).]
• Agreement between measured resting energy expenditure and predicted through Schofield equation. [Срок оценки: During PICU stay, at each Q-NRG+ measurement (up to 5 measurements per patient).]
• Change in measured resting energy expenditure across phases of critical illness. [Срок оценки: Daily during PICU stay, up to 5 Q-NRG+ measurements per patient.]
• Agreement between oxygen consumtion and carbondioxid production derived from blood gas respiratory quotient and Q-NRG+ measurements [Срок оценки: Measurements will be collected from the time of first enrollment until the end of the study (Q2 2026 - Q4 2027).]
• Development of predictive model for resting energy expenditure in critically ill children under 10 kilograms. [Срок оценки: During PICU stay, based on repeated Q-NRG+ measurements (up to 5 measurements per patient).]

Критерии участия

Inclusion Criteria: Newborns and infants admitted to the PICU with body weight from 0,5 up to 10 kilograms. Either requiring mechanically ventilation, with FiO2 < 70%, PIP<30 cmH2O and no leakage in the ventilation system. Or spontaneous breathing patients tolerating measurements with canopy.

Критерии исключения

In mechanically ventilated patients' unstable ventilation including ventilation settings changed during the last 60 minutes (FiO2 >70%, PIP>30 cmH2O, or ventilation system leakage). Patients spontaneous breathing not tolerating measurements with canopy.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Швеция · 1 центр

• Pediatric Perioperative Medicine and Intensive Care Stockholm, Sweden — Stockholm

Публикации

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• Tume LN, Valla FV, Joosten K, Jotterand Chaparro C, Latten L, Marino LV, Macleod I, Moullet C, Pathan N, Rooze S, van Rosmalen J, Verbruggen SCAT. Nutritional support for children during critical illness: European Society of Pediatric and Neonatal Intensive Care (ESPNIC) metabolism, endocrine and nutrition section position statement and clinical recommendations. Intensive Care Med. 2020 Mar;46(3): PMID 32077997
• Mehta NM, Skillman HE, Irving SY, Coss-Bu JA, Vermilyea S, Farrington EA, McKeever L, Hall AM, Goday PS, Braunschweig C. Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Pediatric Critically Ill Patient: Society of Critical Care Medicine and American Society for Parenteral and Enteral Nutrition. JPEN J Parenter Enteral Nutr. 2017 Jul;41(5):706-742. doi: 10.1177/01486 PMID 28686844
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• Joosten KF, Kerklaan D, Verbruggen SC. Nutritional support and the role of the stress response in critically ill children. Curr Opin Clin Nutr Metab Care. 2016 May;19(3):226-33. doi: 10.1097/MCO.0000000000000268. PMID 26963579
• Hulst JM, van Goudoever JB, Zimmermann LJ, Hop WC, Buller HA, Tibboel D, Joosten KF. Adequate feeding and the usefulness of the respiratory quotient in critically ill children. Nutrition. 2005 Feb;21(2):192-8. doi: 10.1016/j.nut.2004.05.020. PMID 15723748
• Gunst J, Vanhorebeek I, Verbruggen SC, Dulfer K, Joosten KF, Van den Berghe G. On how to feed critically ill children in intensive care: A slowly shifting paradigm. Clin Nutr. 2025 Mar;46:169-180. doi: 10.1016/j.clnu.2025.02.003. Epub 2025 Feb 6. PMID 39947042

Идентификаторы

NCT: NCT07462806 · K 2025-0683

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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